federal_register: 2016-28971

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2016-28971 Physiologically Based Pharmacokinetic Analyses-Format and Content; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Physiologically Based Pharmacokinetic Analyses--Format and Content." This guidance recommends to drug sponsors the format and content for submitting physiologically based pharmacokinetic (PBPK) analyses to FDA to enable efficient and consistent review. 2016-12-02 2016 12 https://www.federalregister.gov/documents/2016/12/02/2016-28971/physiologically-based-pharmacokinetic-analyses-format-and-content-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2016-12-02/pdf/2016-28971.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Physiologically Based Pharmacokinetic Analyses--Format and Content." This guidance recommends to drug sponsors the format and...

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